Principal Quantitative Pharmacologist (Pharmacometrician)

As a Principal Quantitative Pharmacologist in Pharmacometrics (PMx) this individual is encouraged to provide contributions to PMx results in support of programs. Is further able to prospectively provide PMx contributions in support of longer-term development strategies implemented over the course of multiple experiments studies and/or clinical trials.

In this role a typical day might include the following:

• Prospectively designs and conducts quantitative or other PMx analyses of a sophisticated nature or otherwise appropriate that is consistent with and encouraging of the program development strategy for one or more program.

• Keeps PMx management advised of significant PMx results.

• As a PMx Program Representative on program teams efficiently communicate sophisticated PMx results in colloquial terms that are understandable across the development teams.

• Implements PMx management strategic or otherwise impactful changes to the program strategy direction and/or regulatory interactions.

• As a PMx Program Representative with limited mentorship from PMx management is responsible for authoring PMx contributions to regulatory documentation such as IBs as well as briefing document for; pre-IND EOP2 and other global Health Authority (HA) meetings.

• Is responsible for the preparation and timely delivery of accurate and well-articulated study reports was well as regulatory submission documents as appropriate.

• Contributes accurate tables and figures for inclusion in slides for senior management presentations.

• Is able to independently draft and review documentation for accuracy clarity and messaging to ensure documents are appropriate for further PMx management review.

• Performs additional analyses as required to support regulatory interactions.

• Share scientific ideas and contribute to the mentoring of PMx staff.

• With some supervision is able to competently represents PMx at pre-IND Type C pre- BLA and other HA meetings.

This role may be for you if you have:

• Understanding of PMx concepts and techniques compartmental modeling translational modelling/pharmacology Exposure-Responses analysis methods Nonlinear Mixed Effects modeling (population PK/PD) logistic regression survival analysis Bayesian approaches disease modelling/QSP*.

• Knowledge of advanced PMx methodologies applicable to clinical trials such as survival analysis stratified or covariate analyses and strategies for handling missing data.

• Has regulatory experience through authoring of regulatory briefing books CTD summaries contribution at HA meetings HA negotiations through regulatory review and approval of BLA or equivalent.

• Proficient in use of analysis tools such as: MS-Excel R R-Studio Phoenix WinNonlin NLME NonMem STAN.

To be considered for this opportunity you will need:

• PhD with 4 years or an MS degree with relevant industry experience. We expect this experience to include advanced pharmacokinetics advanced pharmacological principles non-compartmental analysis methods. Familiarity with other methodologies such as exposure-Response analysis methods translational modelling/pharmacology nonlinear Mixed Effects modeling logistic regression survival analysis Bayesian approaches disease modelling/QSP is also advantageous.

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion or belief (or lack thereof) sex sexual orientation gender identity or expression gender reassignment marital or civil partnership status civil status pregnancy or parental status age disability nationality citizenship status ethnic or national origin membership of the Traveler community familial status genetic information military or veteran status or any other characteristic protected under applicable law. Where required we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process unless such accommodation would impose undue hardship.

Where necessary we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment specific role level and your skills and some countries collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include depending on country and role: annual bonuses or other incentive plans equity awards pension or retirement benefits 401(k) company match health and wellness programs fitness centers insurance benefits (e.g. medical dental vision life and disability) paid time off and family support benefits. For additional information about Regeneron benefits in the U.S. please visit For other locations additional information will be provided during the recruitment process. If you have any questions please speak with your recruiter.

Please be advised that at Regeneron we believe we do our best work when we are together. For that reason many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.

As part of the recruitment process certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)